Laserlux Medical is committed to the highest quality standards. Our services are based on compliance with GMP provisions and rely on ISO 13485:2016 certified Quality Management System. Backed with experience and the commitment to first level service, we recognize the importance and value of building a balanced quality assurance program with full documentation, reporting, and coordination of all processes with our customers.
Company Management has determined that quality is a strategic goal achieved as an ongoing process by means of rules understood by all employees. The company is committed to supply products and service of the highest quality that will meet the needs and requirements of its customers while complying with international regulations and standards. In addition, the company will maintain an open channel of communication with our customers. The company will implement a QMS that defines the organizational structure, responsibilities, procedures and processes required to ensure that the products and service provided are of the highest quality. Company management will provide the resources necessary for the implementation of the QMS and maintaining its effectiveness. In addition, the company will provide skilled employees that will receive training and guidance to improve their professional knowledge.
Company extensive experience in medical device manufacturing and a proven record of success allows us to offer full-scale services from initial runs of prototypes to large volume production. We supply solutions to complex challenges with a focus on providing quality products and leading the way through demanding international compliance requirements.
Providing a wide and full range of services, we are a “One Stop Shop” for multi-disciplinary projects. Our experts work with customers on employee training and qualification; facility, equipment, and process and product validation. We assist our customers through assessment, customers, suppliers, FDA, ISO and CE audits.
Laserlux Medical maintains a state-of-the-art facility for the manufacturing of sterile products. Two independent 70 square meters complexes consist of a dedicated Class 8 washing and preparation room with specially constructed and equipped with laminar hoods path-throughs into Class 7 (ISO 14406) cleanrooms. Each one of the clean rooms has a separate entrance and gowning room which facilitates the process and material flow and ensures full segregation and confidentiality among production lines. Clean rooms are routinely monitored by certified vendors and ISO 17025 accredited microbiology laboratory.